Amryt Pharma (AIM:AMYT ) announced that it has raised $40m at US$12.50p with leading biotech investors to boost working capital and potentially in-license or invest in other rare disease technologies.

Amryt issued 3.2 million American Depositary Shares at a price of US$12.50 each to new and existing shareholders including a roll-call of some of the most influential Biotech investment companies in the World such as Stonepine Capital, Aquilo Capital Management, Amati Global Investors, Athyrium Capital Management and Highbridge Capital Management.

Product Launch

Amryt continues to grow its existing commercial products while it is currently preparing for the launch of its FILSUVEZ® skin product in the US in 4Q21 and in Europe in 1Q22.

The anticipated launch of FILSUVEZ® follows recent positive results from Amryt’s Phase 3 EASE trial, the largest ever global Phase 3 trial conducted in patients with genetic skin disorder Epidermolysis Bullosa (EB), which was performed across 58 sites in 28 countries.    

The trial, which demonstrated the effectiveness of FILSUVEZ® in accelerating wound healing in people with EB, was described by Amryt as “a very important milestone”. The group is seeking to approve FILSUVEZ® as a treatment for EB, for which there are currently none.   

Amryt now intends to complete the submission of its rolling New Drug Application (“NDA”) to the US Food and Drug Administration (“FDA”) and request priority review for FILSUVEZ®.  

Amryt is a biopharmaceutical group developing and delivering innovative new treatments to help improve the lives of patients with rare and orphan diseases with the company comprising a strong and growing portfolio of commercial and development assets.  

Shares in Amryt Pharma have traded within a tight range of 190p and 206p in the past two weeks to open 0.51% lower this morning at 195p following the announcement.

Reasons to Follow Amryt Pharma

Leading Product Portfolio 

Its portfolio includes Amryt's lead development candidate, FILSUVEZ®, a potential treatment for the cutaneous manifestations of EB, a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment.  

In a recent report, CEO,Wiley, highlighted the group’s products metreleptin and lomitapide as delivering growth across revenue, EBITDA, cash generation and market expansion.  

Amyrt’s Myalept® / Myalepta® injection is a leptin replacement therapy used with a doctor-recommended diet to treat problems caused by not having enough leptin in the body. It is approved in the US under the trade name Myalept® and in the EU under Myalepta®.  

Juxtapid®/ Lojuxta® (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia ("HoFH") in the US, Canada, Columbia, Argentina and Japan under the trade name Juxtapid® and in the EU under the trade name Lojuxta®.

New Distribution Partner

Amyrt recently signed a distribution agreement with Swixx BioPharma AG (“Swixx”), a Swiss pharmaceutical agent operating in Central and Eastern Europe (“CEE”) for Lojuxta®.  

The agreement represents new territories for the Group to further accelerate its revenue growth, augmenting sales already being generated through its existing salesforce in the EU.  

Strong Outlook 

Amryt is well positioned in the novel therapeutics market and strong momentum achieved in the year to date has prompted management to upgrade its guidance for FY20 by around 5% to be in the range of $180m-$182m compared to prior guidance of $170m -$175m. 

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